Wednesday, 4 May 2016

The debate about
the melanoma drug Keytruda is an important one, with some very familiar
elements to it.

At its most basic
level, the question is should or should not Keytruda be funded by Pharmac so
that affected patients can potentially benefit from it. So far, Keytruda has
been registered by Medsafe, the medicines regulator, as a pharmaceutical
product that can be legally prescribed in New Zealand. Its clinicial efficacy
has been confirmed by PTAC, the pharmacology and therapeutics committee which
advises Pharmac.

The problem is
that Pharmac has declined to subsidise Keytruda as yet, partly because of its
high cost, partly because the manufacturer has not sought to have it funded,
and partly because it has apparently been keeping an eye on other new medicines
that may become available in this space, and which may be as, or even more
effective, as Keytruda is reported to be. Only this week Medsafe approved a
second melanoma drug, Opvido, which, although very expensive, Pharmac has
agreed to fund from July, presumably becasue it considers it likely to more
effective than Keytruda.

But basically the
issue is a funding one. If there was more funding available to Pharmac, the
argument goes, it would be more likely to be able to fund drugs like Keytruda.
While the government’s announced injection of $124 million into Pharmac’s
budget over the next four years to fund new medicines will undoubtedly help in
this regard, it is not necessarily the end of the argument. In one sense, it
could be argued that more funding could make the circle a more vicious one and
increase the intransigence of rapacious pharmaceutical companies to hold out
for the best prices for their products before making them available. That is
clearly unacceptable, but it is not something over which governments have much
control.

All of this goes
to the heart of why we have a medicines funding system like the Pharmac model.
It used to be the case that the government simply paid whatever price the drug
companies demanded for new and existing medicines, and was effectively held to
ransom by them, in the interests of providing free low cost medicines to
patients. The very notion of part-charges to help meet some of these costs was
strongly resisted as not the way we did things in New Zealand, further
increasing the power of the drug companies to demand the price they wanted.
That was clearly unsustainable. Equally unsustainable was the proposition that
governments should be left to decide what medicines should and should not be made
available on the basis of what they could afford to pay. So the current
medicines registration system, including the development of Pharmac, as the
independent medicines purchaser and price negotiator, was established. This
system has generally worked well over the years, and despite the specific noise
from time to time about particular medicines, there is no general political
appetite for fundament change to it.

While the system
is largely free from political influences, which means medicines decisions are
based primarily on medical efficacy, a fundamental problem still remains. The
power of the international drug companies means they can still effectively hold
countries over a barrel on the prices they will accept for their products,
which means that some medicines are simply too expensive for countries like New
Zealand to afford. The issue with drugs like Keytruda and Opvido, therefore,
will often come down to the deal that Pharmac can negotiate.

However, the
answer is not to meekly surrender to the drug companies’ demands and pay their
prices, as all that will do is encourage them to become even more obstinate
when it comes to new and more innovative medicines, with a potential for more
patients to be denied access to them on affordability grounds. Rather, just as
countries have grouped together to break down trade barriers through
multilateral free trade agreements, like-minded countries should consider
working in concert to break down the stranglehold of the international drug
companies by an international pricing mechanism which ensures that potentially
life-saving medicines are available to those that will benefit from them, not
just those who can afford to pay for them.

Otherwise, the
Keytruda debate is likely to be but one among many yet to come. Science is
giving us the power to conquer illness and disease as never before. It is
surely the responsibility of nations to ensure that power is captured for the good
of their peoples, not just the profits of the multinational drug
companies.